Kornimate/medical-research-clean huggingface dataset:
nanogen pegcyte clinical study for the prevention of cin in breast-cancer patients.

Conditions: Breast Cancer Female

Summary: accelerated ac regimen-doxorubicin 60 mg/m2,cyclophosphamide 600 mg/m2 on day 1 \& day 14 of each cycle along with g-csf support for up to 4 cycles, followed by paclitaxel 175 mg/m2 in the next 4 cycles is the standard clinical practice in vietnam for breast cancer, this regimen is to facilitate the dose-dense schedule, patients receive every-2-week therapy along with g-csf support. the accelerated dose-dense schedule improve disease-free and overall survival among women with breast cancer .primary objective of this study is to compare the efficacy and safety of nanogen's pegcyte and roche's neulastim for prevention of chemotherapy (accelerated ac regimen)-induced neutropenia on breast cancer patients. breast cancer patients scheduled to receive myelosuppressive chemotherapy (ac regimen) will be recruited in this trial. all eligible patients receive single subcutaneous injection of study drugs 24 hours after chemotherapy administration in each cycle for 3 consecutive cycles. efficacy and safety assessments will be assessed based on the incidence of severe neutropenia in combination of temperature \> 38.3℃ or sepsis or life threatening infection and incidence of serious adverse events.


Eligibility criteria:
inclusion criteria: * female patients aged between 18 - 65 years. * patients with histological confirmed primary invasive breast cancer; stage i, ii or iii. * patients had no prior chemotherapy treatments. * patients scheduled to undergo myelosuppressive doxorubicin and cyclophosphamide chemotherapy for 04 cycles, and paclitaxel chemotherapy for the next 04 cycles; patients were available for 14 days of each cycle for the first 03 chemotherapy cycles. * patients with baseline anc ≥ 1.5 x 109/l, plt ≥ 100 x 109/l, hgb ≥ 9 g/dl, wbc ≥ 3,000/ml and albumin ≥ 3.0 g/dl. * performance status as per ecog (eastern cooperative oncology group) score 0, 1 or 2. * willing to give written and signed informed consent. exclusion criteria: * patients with prior exposure of g-csf or gm-csf or its pegylated products in clinical development less than 6 months prior to randomization. * myelotoxic concomitant treatment such as chloramphenicol, methotrexate, immunomodulating agents, interferons during 10 days before randomization. * received systemic antibiotic treatment within 72 hours of chemotherapy. * chronic use of corticosteroids, prior bone marrow or stem cell transplant. * patients who had an immediate/ concurrent exposure to radiotherapy or surgery (within 4 weeks). * severe medical disease: cardiovascular, hepatic, renal, pulmonary... * known cases of hematological disease (sickle cell anemia, aml...) * history of hiv positive, active hepatitis. * pregnant and lactating women or patients planning to become pregnant. * known allergic reactions to study medications. * positive to anti-pegfilgrastim antibody test
major depressive disorder (mdd)

Conditions: Depression

Summary: the purpose of this study is to assess the effectiveness of systematic screening for depression in high-risk patient participants in everyday clinical practice. systematic screening for depression in high-risk patients is recommended to be included as a usual practice but its effectiveness in this context remains controversial. in this study, 35 primary care physicians (pcps) in spain were assigned to intervention (receive one day training in depression screening guidelines and use guidelines for six months) and 34 pcps were assigned to a control group (manage depression in the usual way for six months). there were a total of 525 patient participants with mdd.


Eligibility criteria:
inclusion criteria: * pcp participants: pcps informed of the study design and who agreed to be randomized to the intervention or control group * patient participants: aged 18 years or older who provide a written consent for the collection and use of their clinical data exclusion criteria: * pcp participants: if they already follow the recommendations on screening or were planning to do so. if they will be absent from their practice for a significant period during the study, or if they do not usually manage depression * pcp participants: those who were not able to understand the aims of the study
development of an algorithm to denoise hfno-generated tracheal sound

Conditions: Endoscopy, Gastrointestinal; Sedation, Conscious

Summary: this study aims to develop an algorithm to mitigate the noise generated by the high-flow nasal oxygen system for tracheal sound monitoring in deeply sedated patients.

during deep sedation without intubation, anesthesia respiratory care and monitoring are of utmost importance. anesthesia can lead to adverse respiratory effects, increasing the risk of airway obstruction and respiratory depression. high-flow nasal oxygen (hfno) systems are often used to mitigate these risks. monitoring tracheal breathing sounds directly using amplification provides better detection accuracy. however, traditional auscultation instruments have limitations, including noise interference and lack of visual functionality. the airmod smart respiratory monitoring system, with fda approval in the united states and taiwan, addresses these issues. it offers respiratory sound recording, noise filtering, event logging, and respiratory rate analysis. currently, no digital stethoscope on the market can filter out hfno noise. therefore, the current study is to develop an algorithm to mitigate the noise generated by the high-flow nasal oxygen system for tracheal sound monitoring in deeply sedated patients.

Eligibility criteria:
inclusion criteria: * adult patients undergoing elective gastroinestinal endoscoy requiring deep sedation exclusion criteria: * histories of sleep apnea, chronic obstructive pulmonary disease, or oropharyngeal tumor * patient who has a hisotry of previous intraoral surgery, tracheal surgery or pulmonary resection surgery

Keywords: tracheal sound electronic auscultation high flow nasal oxygen
monitored breathing awareness therapy for insomnia disorder in older adults

Conditions: Insomnia

Summary: insomnia can be a chronic problem that leads to significant daytime fatigue, stress and numerous negative health consequences including depression. advanced medical electronics, in partnership with researchers are the university of pennsylvania, propose developing an innovative, non-drug, low-risk, intervention that can be implemented on mobile devices for the treatment of insomnia.

open-label pilot study in 20 older adults with insomnia (sleep onset latency\>30 minutes for at least 3 nights a week) with a two week intervention period.

Eligibility criteria:
inclusion criteria: 1) sleep onset latency \> 30 min for at least 3 nights per week exclusion criteria: 1. unable to perform tests due to inability to communicate verbally/blindness, inability to write and read in english (the study questionnaires are in english and do not exist in validated form for other languages). 2. cognitive impairment; cognitively impaired patients may not be able to comply with the protocol). 3. history of a diagnosed non-insomnia sleep disorder, such as sleep apnea or circadian rhythm disorder 4. upper extremity motor impairment that would preclude mbat therapy (e.g., quadriplegia).
to investigate the relative efficacy of terbutaline turbuhaler® and salbutamol pressurized metered dose inhaler (pmdi) a single blind study

Conditions: Asthma

Summary: this is a single blind, single dose, crossover study to investigate the relative efficacy of terbutaline turbuhaler® 0.4 mg in relation to salbutamol pressurized metered dose inhaler (pmdi) 200 μg in japanese adult asthmatic patients.the secondary objective of this study is to investigate safety of terbutaline turbuhaler® 0.4 mg in japanese adult asthma patients by means of adverse events (aes) and vital signs (blood pressure, pulse rate). the subject population includes japanese patients (16 years of age or older) with asthma who need treatment with inhaled glucocorticosteroids (ics).


Eligibility criteria:
inclusion criteria: * on ics for at least 3 months from visit 2 and with a prescribed constant dose during the 4 weeks prior to visit 2 * forced expiratory volume in 1 second (fev1) of at least 50 % of predicted normal value pre-bronchodilator * reversible airway obstruction according to reversibility test performed at visit 2, defined as an increase in forced expiratory volume in 1 second (fev1) ≥12% relative baseline at 15-30 minutes after inhalation of in total 400 μg salbutamol exclusion criteria: * treatment with oral, parenteral or rectal gcs (glucocorticosteroids)within 4 weeks or depot parenteral gcs (glucocorticosteroids) within 3 months prior to visit 2. * change in prescribed asthma medication due to exacerbation of asthma within 4 weeks prior to visit 2 or being hospitalized due to exacerbation of asthma within 8 weeks prior to visit 2.

Keywords: terbutaline turbuhaler efficacy asthma japanese salbutamol bricanyl
screening of abdominal aortic aneurysms among men with coronary artery disease

Conditions: Abdominal Aortic Aneurysm

Summary: the purpose of this study is to investigate prevalence of abdominal aortic aneurysms (aaa) among male patients with coronary artery disease (cad). secondary purpose is to document cost-effectiveness of ultrasound screening of aaa in selected population. ethiology of aaa is known to be common with atherosclerotic arterial diseases, and on the basis of our previous studies (clinicaltrials.gov id cad-aaa-02) the prevalence of aaa seems to be higher in cad population than unselected male population. this leads to hypothesis that selective screening of these patients (for aaa) could be cost-efficient and life saving option for detecting aaas before rupture. study will be carried out as a single-center prospective screening study. patients will be selected for this study on basis of their icd 10 diagnose codes in north carelian patient information system. inclusion criteria will be any kind of atherosclerotic heart disease (icd10 codes i20-i25). criteria for exclusion are malignant disease, already diagnosed or treated aaa and failure to give informed consent. 800 patient records that meet the inclusion criteria will be reviewed for eligibility. invitations for screening will be sent for 600 patients with intention to have at least 400 patients screened. screening will be done by verified sonographers in designated screening appointments.


Eligibility criteria:
inclusion criteria: * male patients with coronary artery disease exclusion criteria: * already diagnosed or treated abdominal aortic aneurysm * patient's denial to participate * malignant disease
the reduced-i pilot trial: reducing the utilization of cesarean sections with induction

Conditions: Induced; Birth

Summary: this pilot project is a randomized controlled trial where induced patients receive an intervention of oxytocin discontinuation once in the active stage of labor (≥6 cm dilation). the intent is to reduce uterine hyperstimulation and fetal distress, therefore, lowering cesarean sections (cs) in first time mothers at term (≥ 37 weeks), with a cephalic presenting singleton fetus, without increasing maternal or neonatal morbidity. if reduce-i pilot trial suggests a safe reduction in cs rates and patient satisfaction, application for a multi-centre randomized controlled trial would follow.

this pilot project is a randomized controlled trial of a proposed intervention to modify management of labor inductions once in the active first stage of labor. the intervention will take place at foothills medical centre (fmc). randomization will be computer generated, participants will be stratified by need for cervical ripening and randomization will be blocked. participants will be primiparous women 18 years old or older, at term (≥ 37 weeks) with a cephalic presenting singelton fetus undergoing induction of labor with oxytocin. once patients are in the active first stage of labor, study medication will be initiated (identical vials of oxytocin or saline prepared by the alberta health services research pharmacy). treatment period will continue until delivery. if the frequency of contractions are reduced to less than 2 in 10 minutes or there has been no change in dilation for 4 hours, then oxytocin can be restarted. royal alexandra hospital in edmonton will be used as a contemporaneous non-intervention control site.

Eligibility criteria:
inclusion criteria: * pregnant women undergoing induction of labor with oxytocin. * primiparous * 18 years old or older * at term (≥37 weeks) * cephalic presenting * singleton fetus exclusion criteria: * multiple pregnancies * known fetal congenital or chromosomal anomalies

Keywords: obstetric labor complications cesarean section induced labour oxytocin
influence of cbd on episodic memory in healthy subjects

Conditions: Healthy

Summary: placebo controlled, randomized, double blind, cross-over design. single vape of 0.25ml 5% cbd e-liquid (12.5mg cbd) and single vape of 0.25ml e-liquid, tastes like lemon and madeleine. 15min vape time each. a total of 34 participants, equal number of male and female. there will be replacement of drop-outs until data from 34 participants are completed. the primary endpoint will be performance in a verbal memory task. the secondary endpoint will be performance in a working memory test.


Eligibility criteria:
inclusion criteria: * healthy * normotensive (bp between 90/60mmhg and 140/90mmhg) * bmi between 18 and 30 kg/m2 * male or female * aged between 18 and 30 years * native or fluent german-speaking * able and willing to give written informed consent as documented by signature and comply with the requirements of the study protocol * willing to donate urine sample to control for pre-visit cbd/thc consume exclusion criteria: * acute or chronic psychiatric disorder including drug or alcohol abuse * women who are pregnant or breast feeding * intention to become pregnant during the course of the study * smoking (\> 5 cigarettes per day) * participation in one of our previous studies using the same verbal test in the past 2 years * participation in a study with cbd / thc within the 30 days preceding and during the present study * known hypersensitivity or allergy to propylene glycol * intake of cbd / thc within the 7 days preceding and during the present study in any application form * long-term systemic medication or topical steroids to treat an underlying disease within last 3 months * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * enrolment of the investigator, his/her family members, employees and other dependent persons
magic cell-5-combicytokine trial

Conditions: Acute Myocardial Infarction

Summary: combination use of darbepoetin and g-csf will improve left ventricular systolic function in patients with acute myocardial infarction who receive intracoronary infusion of mobilized peripheral blood stem cell in comparison with patient who treated with conventional measures and who received intracoronary infusion of mobilized peripheral blood stem cell by g-csf alone.


Eligibility criteria:
inclusion criteria: * st elevation acute myocardial infarction * \< 80years * successful revascularization of culprit vessel exclusion criteria: * uncontrolled congestive heart failure * uncontrolled myocardial ischemia * uncontrolled ventricular arrhythmia * malignancy * serious hematologic disease * chronic renal failure

Keywords: acute myocardial infarction
reduction in iv associated contamination

Conditions: Post-operative Infections

Summary: the purpose of this study is to investigate whether implementing a novel syringe and iv stopcock cap system impregnated with alcohol will reduce iv catheter bacterial contamination and infections in patients.

bacterial contamination of patient intravenous stopcock sets is a common intraoperative event associated with increased patient mortality, possibly via an infectious mechanism. the most common type of intravenous tubing used in operating rooms is the open lumen stopcock set which lacks a barrier between the environment and intraluminal space, and thus the intravascular space of the patient. the stopcock connector can be easily contaminated by provider hands due to improper handling of the device and/or contaminated by soiled syringe tips subsequently connected to the device. further, the stopcock connector is often left uncapped by the provider and directly exposed to the environment. thus, common breaches in intraoperative aseptic practice of healthcare providers can lead to bacterial contamination of the endoluminal space of the open lumen device. the primary aim of the current study is to assess the efficacy of a passive bundle designed to decrease intravenous stopcock and tubing intraluminal bacterial contamination. this passive bundle includes two novel interventions, a docit station and hubscrub caps. the hubscrub is designed to clean the needleless connectors and open lumen stopcock systems. the docit station is designed to simultaneously clean the interior and exterior of needle-less luer connectors of syringes with isopropyl alcohol while also providing a method of storage and organization of multiple syringes. the investigators hypothesize that the application of this passive bundle to the standard open lumen system commonly employed by anesthesia providers in the operating room will significantly reduce bacterial contamination of standard 3-way open lumen stopcock sets and improve patient safety.

Eligibility criteria:
inclusion criteria: * adult patient undergoing surgery or procedure in operating room * undergoing general anesthesia exclusion criteria: * children (age \< 18 years) * lack of intravenous access * failure of anesthesia provider to complete training on experimental device

Keywords: iv contamination intravenous contamination stopcock contamination surgical site infection
a study to evaluate the efficacy and safety of abt-493/abt-530 in subjects with genotype 1 infection

Conditions: Chronic Hepatitis C; Hepatitis C Virus; HCV

Summary: this study seeks to evaluate the efficacy and safety of abt-493/abt-530 in participants with genotype 1 hepatitis c virus infection without cirrhosis


Eligibility criteria:
inclusion criteria: * male or female, at least 18 years of age at time of screening. * screening laboratory result indicating hepatitis c virus (hcv) genotype 1 (gt1) infection. * chronic hcv infection. * subject must be hcv treatment-naïve (i.e., patient has never received a single dose of any approved or investigational regimen) or treatment-experienced (has failed prior interferon \[ifn\] or pegylated ifn (pegifn) with or without ribivarin (rbv), or sofosbuvir (sof) plus rbv with or without pegifn therapy). * subjects must be non-cirrhotic. additional inclusion criteria for hcv gt1/human immununovirus type 1 (hiv-1) co-infected patients: * hiv-1 antiretroviral treatment (art) naïve with cd4 ≥ 500 cells/mm3 (or cd4+ % ≥ 29%) at screening and plasma hiv-1 rna \<1,000 copies/ml at screening and at least once during the 12 months prior to screening. or * on a stable, qualifying hiv-1 art regimen for at least 8 weeks prior to screening, with cd4 ≥ 200 cells/mm3 (or cd4+ % ≥14%) at screening and plasma hiv-1 rna \< lloq at screening and at least once during the 12 months prior to screening. exclusion criteria: * history of severe, life-threatening or other significant sensitivity to any excipients of the study drugs. * female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study. * recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator. * positive test result at screening for hepatitis b surface antigen (hbsag). * hcv genotype performed during screening indicating co-infection with more than one hcv genotype. * chronic hiv type 2 (hiv-2) infection.

Keywords: hcv gt1 non-cirrhotic rbv free without cirrhosis chronic hepatitis c hepatitis c genotype 1 (gt1) ifn free hepatitis c ribavirin free interferon (ifn) free hcv hepatitis c virus daa
improved sitting balance: body functions to participation

Conditions: Cerebral Palsy

Summary: the aim of this study is to evaluate the changes in activity and participation domains of international classification of functioning, disability and health (icf) in children with cerebral palsy (cp) who received integrated botulinum toxin-a (bont-a) injections into the lower limb(s) with a treatment goal of improved sitting balance.

postural problems play a substantial role in activities of daily living in children with cp having gross motor function classification system (gmfcs) levels iv or v. improvement in sitting balance may positively effect the performance and caregiving of vital tasks of daily life in these children and may furtherly improve the quality of life of both the child and family. bont-a is an important treatment in children with cp because it is safe in young children and allows combined treatment. in the current literature its efficacy on body functions and structures by hypertonia management is well known. however there is inconclusive evidence for improvement in activity and participation domains of icf with bont-a. cp is a very heterogenous population and in most of the studies the inclusion criteria do not adress level of underlying motor control and the primary efficacy assessment methods were usually chosen to cover hypertonia. besides generally the efficacy endpoints were so soon to detect changes in activity or participation domains of icf. lack of association of rehabilitation programs is another important concern for the current clinical studies. in this present study a well defined subpopulation of cp children having gmfcs levels of iv or v who each received integrated bont-a treatment with a primary goal of improved sitting balance will be recruited to identify the probable changes in activity and participation domains of icf as well as changes in quality of life of the family and the child.

Eligibility criteria:
inclusion criteria: * all children with a diagnosis of cerebral palsy with respect to rosenbaum criteria * gross motor functional classification scale level of iv-v * being scheduled for bont-a treatment to lower extremity * primary goal of treatment selected as improved sitting balance exclusion criteria: * severe cognitive or behavioural problems * severe dystonia

Keywords: cerebral palsy, botulinum toxin a, participation